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Completed Phase 3 Interventional Results available

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

ClinicalTrials.gov ID: NCT05064059

Public ClinicalTrials.gov record NCT05064059. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 12:54 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (KEYFORM-007)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.

Study identification

NCT ID
NCT05064059
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Merck Sharp & Dohme LLC
Industry
Enrollment
441 participants

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 10, 2021 (Actual)
Primary completion
Aug 15, 2024 (Actual)
Completion
Feb 21, 2025 (Actual)
Last update posted
May 26, 2026

2021 – 2025

United States locations

U.S. sites
15
U.S. states
12
U.S. cities
14
Facility City State ZIP Site status
Georgetown University Hospital ( Site 1148) Washington D.C. District of Columbia 20007 —
Sibley Memorial Hospital ( Site 1143) Washington D.C. District of Columbia 20016 —
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1118) Marietta Georgia 30060 —
Norton Cancer Institute ( Site 1139) Louisville Kentucky 40217 —
Rutgers Cancer Institute of New Jersey ( Site 1105) New Brunswick New Jersey 08903 —
Memorial Sloan Kettering Cancer Center ( Site 1703) New York New York 10065 —
Oregon Health & Science University ( Site 1141) Portland Oregon 97239 —
MUSC Hollings Cancer Center ( Site 1715) Charleston South Carolina 29425 —
The West Clinic, PLLC dba West Cancer Center ( Site 1149) Germantown Tennessee 38138 —
UT Southwestern Medical Center ( Site 1709) Dallas Texas 75390-9063 —
Intermountain Medical Center ( Site 1707) Murray Utah 84107 —
Inova Schar Cancer Institute ( Site 1130) Fairfax Virginia 22031 —
VCU Health Adult Outpatient Pavillion ( Site 1712) Richmond Virginia 23219 —
Blue Ridge Cancer Care ( Site 1718) Roanoke Virginia 24014 —
Seattle Cancer Care Alliance ( Site 1107) Seattle Washington 98109 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 137 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05064059, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 26, 2026 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05064059 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →